Existing fluid connectors are typically designed without a covering for protecting the access site while it is not in use. Some access sites include screw threads which allow them to more easily be connected to IV tubing during lengthy accesses. However, most external fluid connectors normally remain uncovered and completely exposed with little or no barrier to potential contaminants. Contaminants may include, but are not limited to, germs, bacteria, air, dirt, clothing, skin and perspiration.
Because of the exposure of the fluid connector and access site to contaminants, the use of an aseptic cleansing procedure is typically required prior to accessing the site. Using currently accepted techniques, the cleansing process alone involves several steps and the use of numerous materials for each port access. In order to assure an aseptic environment, a second person may be needed to assist the first with the cleansing process. The clinician may not disinfect the access site for various reasons, including forgetting to do so, not having the appropriate disinfectant swab readily available, being in a hurry, not understanding the importance or a combination of these issues.
When access to the fluid connector is complete, it will again come into contact with the patient's skin or clothing and immediately become susceptible to contamination, requiring repetition of the above procedure the next time the access site is accessed. The cleansing procedure, even if properly followed, is very time consuming. Materials must be gathered prior to access, and an assistant may be required before the procedure can be started. The more frequent the access, the greater the risk of subsequent contamination.
Recent scientific studies suggest that the external access site of a fluid connector may be the place of origin of bacteria infecting the fluid connector. These studies recommend that manipulation of the access site be kept at a minimum, and that a more rigorous approach to aseptic technique be undertaken such as the time consuming, expensive and difficult measures as discuss above. While studies have suggested that the hub of catheter devices be properly covered, such studies fail to propose any cover design apart from indicating covers are needed to protect against contamination.
While external injection port covers directed to maintaining sterility of catheter hubs have been disclosed, these external injection port cover designs require that the cover include threaded elements to securably cover the corresponding threaded elements of the fluid connector. Thus, the cover requires manual manipulation for removal and replacement thereof on the fluid connector and may require a unique design for each fluid connector. Moreover, the covers are often lost or discarded and not replaced. Minimization of such manipulation, and eliminating loss of the cover, and providing a universal, passive design of an aseptic cover for fluid connectors would improve the compliance and sterility of the fluid connector manipulations.